“In in vitro studies, olaratumab bound to human and cynomolgus monkey PDGFR-α with similar affinity, but did not bind appreciably to mouse or rabbit PDGFR-α, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”
✓ VerifiedFDA multi-discipline review, p. 29Source ↗
Why that species
Binds human and monkey PDGFRα with similar affinity; no appreciable binding to mouse or rabbit PDGFRα
“In in vitro studies, olaratumab bound to human and cynomolgus monkey PDGFR-α with similar affinity, but did not bind appreciably to mouse or rabbit PDGFR-α, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”
✓ VerifiedFDA multi-discipline review, p. 29Source ↗
Surrogate molecule
Yes: chimeric anti-mouse PDGFRα antibody IMC-1E10, used for mouse embryo-fetal development study
“the Applicant provided a scientific literature review and assessment of the potential reproductive toxicity of olaratumab in conjunction with an embryo-fetal development study in mice using a chimeric surrogate antibody, IMC-1E10.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗